Bio-Business Summit - 2005 "Global Clinical Trials in India - Prospects & Challenges "
November 14-16, 2005, New Delhi

Address by Smt. Panabaka Lakshmi, Hon'ble Minister of State for Health and Family Welfare, Govt. of India

Shri Onkar S. Kanwar, President, FICCI; Dr. M.K. Bhan, Secretary, Department of Bio-technology; Dr. N.K. Ganguly, Director General, ICMR; Dr. David A. Lepay, Sr. Advisor for Clinical Science and Director; Dr. Altaf Lal, Health Attache & Regional, Representative for South Asia, US Embassy, India; Dr. Krishna Ella, Chairman, FICCI, Dr. Amit Mitra, Secretary General FICCI;

As you are all aware that health is a prime concern of all citizens and success of health care depends on effective implementation of delivery programmes like Health Camps and early access to safe and effective drugs, Vaccines and other health care products. There is a growing realization that the economic growth of a nation is intrinsically linked to the health status of its people. Government's policy objectives are, to provide basic package of preventive, promotive and curative health services to all our citizens.

Though substantial achievement has been made since independence in terms of increase in life span from 32 years to 66 years, our health care problems like infant mortality rate, TB, Leprosy and Polio etc. continue to challenge us on many fronts.

Thus, calls for committed involvement of all concerned especially the health care providers and the research scientists. Investing in health care is investing in country's development.

Fortunately, Indian pharmaceutical sector which has made a pheonomenal progress in last few decades, has enabled access to high quality affordable drugs and self-sufficiency in availability of most of essential drugs and vaccines for majority of country's population. The credit goes to Indian pharmaceutical sector for having emerged as the 4th largest producer of drugs in the world by volume.

The advances made by the pharma sector in terms of technology and good manufacturing methods and practices is commendable. Its spending on Research and Development is considered to be the highest among all the industrial sector in the country .

The drug discovery research and product development are highly knowledge demanding, risk prone and high cost activities.

Our coordination and association in global efforts in drug discovery research afford us to boost our indigenous efforts in discovery of new drugs and vaccines had undergone a tremendous change in last few decades.

The break through in science in recent years has provided us spectacular, understanding in genome mapping, genetic engineering, stem cell research etc.

"Good Clinical Practices" as well as "ethics", to be followed while conducting clinical trials has to be seen as shared responsibility amongst sponsors, clinical investigators, ethics committees and the regulatory bodies. In recent years, the Indian government has taken number of initiatives, to enable our medical institutions and clinicians, in conducting clinical trials to conform to the globally accepted norms. Apart from publishing our national guidelines on GCPs, the Drugs and Cosmetics Rules have also been extensively amended to suit the needs of changing times and India's potential to associate in global drug discovery research.

As our share in global clinical research increases, number of challenges would have to be met along with opportunities thrown by this intellectual activity. The need of the hour is to identify the deficiencies and prepare for the challenges much in advance by all concerned and to address them in an effective and speedy manner.

As you are aware that the National Common Minimum Programme of the Government, drafted under the able guidance of Smt. Sonia Gandhi, Chairperson of the National Advisory Council, has envisaged health care as one of the seven priority areas for holistic and sustainable development of the country. Further, the UPA Government under the visionary leadership of Hon'ble Prime Minister Dr Manmohan Singh with strategies for improving the health status of the poorer, disadvantaged and marginalized population. One such endeavour is launching of 'Rural health Mission' throughout the country recently .

I am happy to note that the FICCI has taken the initiative, to involve all concerned to undertake an in depth and critical examination of all aspects related to India's opportunities and challenges in becoming a respected and leading associate in global clinical trials.

Thank you,

Jai Hind